The present invention relates to a container for a suspension in gel of molecules of a medicine, a herbal remedy, a homeopathic or cosmetic product, carbon dioxide, oxygen, or nitrogen to be transported, or of other molecules or substances to be administered by iontophoresis, or by other methods requiring the application of energy which promotes the penetration of the molecules to be transported through the epidermis and beyond the cutaneous barrier of the skin.
Iontophoresis as a method of transcutaneous administration of medicines or other products for various purposes is known. This method can be used to place ionizable molecules of a substance to be transported in a container and then to bring one part of the container into contact with the skin of the patient to whom the substance is to be administered. In the part to be brought into contact with the skin, the container is closed by an osmotic or partially permeable membrane. The patient and the container in which the molecules to be transported are kept are connected in an electrical circuit with a source of voltage and/or frequency which can be varied in a controlled way, which causes the ionization of the molecules and the migration of the ions through the osmotic membrane and through the patient""s skin and consequently their entry into the tissues lying under the epidermis, to a depth determined by the frequency applied. The circuit is completed by means of one or more electrodes applied to suitable parts of the body of the patient being treated.
Various kinds of iontophoresis equipment are described in the literature. For example, EP-A-0292930 describes equipment in which the container for the solution containing the molecules to be transported has an osmotic membrane through which the ions generated by the electrical field produced by a suitable apparatus migrate. The molecules are contained in liquid solution inside the container which is sealed by the osmotic membrane.
U.S. Pat. No. 5,084,008 describes a different container for the medicine to be administered by iontophoresis. In this case, the container is particularly suitable for the use of molecules to be transported which are contained in a gel, and is closed by a permeable layer which has the purpose of allowing the passage of the ions and at the same time of preventing the gel from drying out during the period for which the container is stored. The container is characterized by a particular configuration of the means of distributing the current within the medicine.
WO-8808729 describes an electrode for iontophoresis, consisting of a plate of conducting material to which is applied a porous membrane within which the molecules to be transported are placed. The membrane is protected by a removable protective sheet which is removed at the moment of application of the electrode to the patient.
WO-9622810 describes a container for a medicine to be administered by iontophoresis following the freezing of the solution containing the medicine. In this case, the container is made in two portions joined together in a reversible way and forming an internal volume in which the solution containing the medicine to be administered is placed. The container with its contents is then frozen, and at the moment of use the upper part of the container is removed to expose a block formed by the frozen solution. This block is brought into contact with the patient""s epidermis. The part of the container which is not removed, and in which the base of the block of frozen solution continues to be housed, contains the electrode which has a shape suitable for providing electrical contact with the frozen block of solution.
This container has considerable drawbacks, due to the lack of arrangements for reliably fixing the two portions of the container to each other when the container has to be filled with the solution containing the medicine, the lack of a suitable seal to ensure the hygiene of the product, since the container is open at the top to allow filling, and the impossibility of ensuring that the container is used once only for reasons of hygiene. Furthermore, this container is suitably solely and exclusively for the application of previously frozen solutions. The application of the electrode is insecure and it can easily be immersed as a result of the melting of the block of ice, with the risk of electrical discharges.
Other known methods of administration of active principles through the epidermis require the use of forms of energy other than electrical energy. For example, it is known that an active principle can be made to pass through the epidermis by irradiation with a laser, and particularly with a diode laser. Another method may require administration by means of ultrasound, by means of infrared radiation, or by other means.
In the present description, reference will be made in general terms to a source of energy and to means for directing this energy toward the solution containing the molecules to be transported. This wording is to be understood as denoting any system which enables active principles or molecules of any type to be administered by a transcutaneous route by means of the supply of energy in any form.
Within the present description, reference will be made specifically to iontophoresis, as a particularly advantageous method of administration. However, this is to be considered as an indication of a preferred, but not exclusive, form of application of the present invention.
The object of the present invention is to provide a container for a carrier product of relatively high viscosity, such as a gel or the like, containing molecules to be transported by iontophoresis, which overcomes the drawbacks and limitations of the conventional containers known at the present time.
More generally, the object of the present invention is to provide a container and dispenser device suitable for use with any method of administration of principles dispersed in said carrier product by the use of a source of energy. The device comprises, in combination,
a container for said product;
a dispensing element through which said product is dispensed;
an energy supply component located adjacent to said dispensing element.
The container has a main body and, if necessary, a dispensing chamber where said dispensing element and said energy supply component are located, and it is also possible for said dispensing chamber to be applicable in a reversible way to the main body of the container.
Said dispensing element can be a rotating element or a piece of felt or other permeable body, and can also be formed from electrically conducting material. In this case it can be brought into electrical contact with said energy supply component, to apply an electrical potential directly to the epidermis.
The container can have a tapered portion at whose end said dispensing element and said supply component are located, and/or can have walls which are at least partly flexible, to enable pressure to be applied manually to the contents of the device to facilitate dispensing.